pamidronate Injectable Solution
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Hospira Worldwide, Inc. (2014-07-22)
- Oldest Current Product
- 2002-04-01
- License(s)
- ANDA
- RxNORM
- INJECTABLE SOLUTION\PAMIDRONATE
- FDAOB
- INJECTION\INJECTION\PAMIDRONATE DISODIUM\rdfq
- SPL Active
- INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\PAMIDRONATE DISODIUM
INTRAVENOUS\INJECTION, SOLUTION\PAMIDRONATE DISODIUM
INTRAVENOUS\INJECTION\PAMIDRONATE DISODIUM - SPL Moiety
- INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\PAMIDRONIC ACID
INTRAVENOUS\INJECTION, SOLUTION\PAMIDRONIC ACID
INTRAVENOUS\INJECTION\PAMIDRONIC ACID
product(s) by strength(s)
pamidronate disodium 3 mg/ml injectable solution
original product(s)(s)
| # | id | labeler | active ingredient(s) | route | dose form | spl |
|---|---|---|---|---|---|---|
| 1 | 005170745 | American Regent, Inc. | PAMIDRONATE DISODIUM | INTRAVENOUS | INJECTION, SOLUTION | 9337c108-2d51-4322-be3c-f3e879069f86 |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 000690107 | ANDA | Pfizer Labs | 2011-05-10 | PAMIDRONATE DISODIUM | INTRAVENOUS | INJECTION, SOLUTION | ANDA078520 | a8ba3ed0-7047-400e-8037-ebc058024637 |
| 2 | 000690186 | ANDA | Pfizer Labs | 2011-05-10 | PAMIDRONATE DISODIUM | INTRAVENOUS | INJECTION, SOLUTION | ANDA078520 | ebd26191-b497-4904-b158-ca3b0bcd178b |
| 3 | 007034075 | ANDA | Teva Parenteral Medicines, Inc | 2002-04-01 | PAMIDRONATE DISODIUM | INTRAVENOUS | INJECTION, SOLUTION | ANDA076153 | d3f15563-21af-4e0d-a9f1-1ebc596c848f |
| 4 | 250210802 | ANDA | Sagent Pharmaceuticals | 2010-01-15 | PAMIDRONATE DISODIUM | INTRAVENOUS | INJECTION | ANDA078373 | 246ad093-0419-48a2-8d11-f2c5806156c1 |
| 5 | 599230601 | ANDA | Areva Pharmaceuticals,Inc. | 2013-08-06 | PAMIDRONATE DISODIUM | INTRAVENOUS | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA077433 | 5db8c103-2bfd-a235-d50d-4c1a356d44d2 |
| 6 | 617030324 | ANDA | Hospira Worldwide, Inc. | 2002-06-27 | PAMIDRONATE DISODIUM | INTRAVENOUS | INJECTION, SOLUTION | ANDA075841 | 9b6a9a3b-71c9-4dcb-b857-5d1de25c3a23 |
| 7 | 633230734 | ANDA | App Pharmaceuticals, Llc | 2002-05-19 | PAMIDRONATE DISODIUM | INTRAVENOUS | INJECTION, SOLUTION | ANDA076207 | ad1b83f9-ddf7-44b7-9234-77d6872e4825 |
| 8 | 674570430 | ANDA | Mylan Institutional Llc | 2008-11-01 | PAMIDRONATE DISODIUM | INTRAVENOUS | INJECTION | ANDA078520 | c2ca033e-fa5f-4141-b702-11f8b4303da1 |
pamidronate disodium 6 mg/ml injectable solution
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 599230602 | ANDA | Areva Pharmaceuticals,Inc. | 2013-08-06 | PAMIDRONATE DISODIUM | INTRAVENOUS | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA077433 | 5db8c103-2bfd-a235-d50d-4c1a356d44d2 |
| 2 | 617030325 | ANDA | Hospira Worldwide, Inc. | 2002-06-27 | PAMIDRONATE DISODIUM | INTRAVENOUS | INJECTION, SOLUTION | ANDA075841 | 9b6a9a3b-71c9-4dcb-b857-5d1de25c3a23 |
pamidronate disodium 9 mg/ml injectable solution
original product(s)(s)
| # | id | labeler | active ingredient(s) | route | dose form | spl |
|---|---|---|---|---|---|---|
| 1 | 005170746 | American Regent, Inc. | PAMIDRONATE DISODIUM | INTRAVENOUS | INJECTION, SOLUTION | 9337c108-2d51-4322-be3c-f3e879069f86 |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 000690109 | ANDA | Pfizer Labs | 2011-05-10 | PAMIDRONATE DISODIUM | INTRAVENOUS | INJECTION, SOLUTION | ANDA078520 | a8ba3ed0-7047-400e-8037-ebc058024637 |
| 2 | 007034085 | ANDA | Teva Parenteral Medicines, Inc | 2002-04-01 | PAMIDRONATE DISODIUM | INTRAVENOUS | INJECTION, SOLUTION | ANDA076153 | d3f15563-21af-4e0d-a9f1-1ebc596c848f |
| 3 | 250210803 | ANDA | Sagent Pharmaceuticals | 2010-01-15 | PAMIDRONATE DISODIUM | INTRAVENOUS | INJECTION | ANDA078373 | 246ad093-0419-48a2-8d11-f2c5806156c1 |
| 4 | 599230603 | ANDA | Areva Pharmaceuticals,Inc. | 2013-08-06 | PAMIDRONATE DISODIUM | INTRAVENOUS | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA077433 | 5db8c103-2bfd-a235-d50d-4c1a356d44d2 |
| 5 | 617030326 | ANDA | Hospira Worldwide, Inc. | 2002-06-27 | PAMIDRONATE DISODIUM | INTRAVENOUS | INJECTION, SOLUTION | ANDA075841 | 9b6a9a3b-71c9-4dcb-b857-5d1de25c3a23 |
| 6 | 633230735 | ANDA | App Pharmaceuticals, Llc | 2002-05-19 | PAMIDRONATE DISODIUM | INTRAVENOUS | INJECTION, SOLUTION | ANDA076207 | ad1b83f9-ddf7-44b7-9234-77d6872e4825 |
| 7 | 674570610 | ANDA | Mylan Institutional Llc | 2008-11-01 | PAMIDRONATE DISODIUM | INTRAVENOUS | INJECTION | ANDA078520 | 82e8deb5-2368-4267-8286-b7782acca952 |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA075290 | PAMIDRONATE DISODIUM | EUROHEALTH INTERNATIONAL SARL | 2001-04-30 | ANDA075290_001, ANDA075290_003 | |
| 2 | ANDA075594 | PAMIDRONATE DISODIUM | True | AESGEN INC | 2002-05-06 | ANDA075594_001, ANDA075594_002 |
| 3 | ANDA075773 | PAMIDRONATE DISODIUM | FRESENIUS KABI USA LLC | 2002-05-06 | ANDA075773_001, ANDA075773_002 | |
| 4 | ANDA075841 | PAMIDRONATE DISODIUM | HOSPIRA INC | 2002-06-27 | ANDA075841_001, ANDA075841_002, ANDA075841_003 | |
| 5 | ANDA076153 | PAMIDRONATE DISODIUM | TEVA PHARMACEUTICALS USA | 2002-03-27 | ANDA076153_001, ANDA076153_002 | |
| 6 | ANDA076207 | PAMIDRONATE DISODIUM | FRESENIUS KABI USA LLC | 2002-05-17 | ANDA076207_001, ANDA076207_002 | |
| 7 | ANDA077433 | PAMIDRONATE DISODIUM | AREVA PHARMACEUTICALS INC | 2008-11-26 | ANDA077433_001, ANDA077433_002, ANDA077433_003 | |
| 8 | ANDA077703 | PAMIDRONATE DISODIUM | SUN PHARMA GLOBAL INC | 2008-12-24 | ANDA077703_001, ANDA077703_002 | |
| 9 | ANDA078156 | PAMIDRONATE DISODIUM | PLIVA LACHEMA AS | 2008-08-19 | ANDA078156_001, ANDA078156_002, ANDA078156_003 | |
| 10 | ANDA078300 | PAMIDRONATE DISODIUM | True | MN PHARMACEUTICALS | 2009-03-10 | ANDA078300_001, ANDA078300_002 |
| 11 | ANDA078373 | PAMIDRONATE DISODIUM | MUSTAFA NEVZAT ILAC SANAYII AS | 2008-12-23 | ANDA078373_001, ANDA078373_002 | |
| 12 | ANDA078520 | PAMIDRONATE DISODIUM | MYLAN LABORATORIES LTD | 2008-10-31 | ANDA078520_001, ANDA078520_002 | |
| 13 | ANDA078942 | PAMIDRONATE DISODIUM | LUITPOLD PHARMACEUTICALS INC | 2008-07-25 | ANDA078942_001, ANDA078942_002 | |
| 14 | NDA020036 | AREDIA | True | NOVARTIS PHARMACEUTICALS CORP | 1991-10-31 | NDA020036_001, NDA020036_003, NDA020036_004 |
| 15 | NDA021113 | PAMIDRONATE DISODIUM | EUROHEALTH INTERNATIONAL SARL | 2002-03-04 | NDA021113_001, NDA021113_002 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | ANDA075290_001 | RX | PAMIDRONATE DISODIUM (30MG/VIAL) | INJECTION | False | AP | 2001-04-30 | PAMIDRONATE DISODIUM |
| 2 | ANDA075290_003 | RX | PAMIDRONATE DISODIUM (90MG/VIAL) | INJECTION | False | AP | 2001-04-30 | PAMIDRONATE DISODIUM |
| 3 | ANDA075594_001 | discontinued | PAMIDRONATE DISODIUM (30MG/VIAL) | INJECTION | False | 2002-05-06 | PAMIDRONATE DISODIUM | |
| 4 | ANDA075594_002 | discontinued | PAMIDRONATE DISODIUM (90MG/VIAL) | INJECTION | False | 2002-05-06 | PAMIDRONATE DISODIUM | |
| 5 | ANDA075773_001 | RX | PAMIDRONATE DISODIUM (30MG/VIAL) | INJECTION | False | AP | 2002-05-06 | PAMIDRONATE DISODIUM |
| 6 | ANDA075773_002 | RX | PAMIDRONATE DISODIUM (90MG/VIAL) | INJECTION | False | AP | 2002-05-06 | PAMIDRONATE DISODIUM |
| 7 | ANDA075841_001 | RX | PAMIDRONATE DISODIUM (30MG/10ML) | INJECTION | True | AP | 2002-06-27 | PAMIDRONATE DISODIUM |
| 8 | ANDA075841_002 | RX | PAMIDRONATE DISODIUM (60MG/10ML) | INJECTION | True | AP | 2002-06-27 | PAMIDRONATE DISODIUM |
| 9 | ANDA075841_003 | RX | PAMIDRONATE DISODIUM (90MG/10ML) | INJECTION | True | AP | 2002-06-27 | PAMIDRONATE DISODIUM |
| 10 | ANDA076153_001 | RX | PAMIDRONATE DISODIUM (30MG/10ML) | INJECTION | False | AP | 2002-03-27 | PAMIDRONATE DISODIUM |
| 11 | ANDA076153_002 | RX | PAMIDRONATE DISODIUM (90MG/10ML) | INJECTION | False | AP | 2002-03-27 | PAMIDRONATE DISODIUM |
| 12 | ANDA076207_001 | RX | PAMIDRONATE DISODIUM (30MG/10ML) | INJECTION | False | AP | 2002-05-17 | PAMIDRONATE DISODIUM |
| 13 | ANDA076207_002 | RX | PAMIDRONATE DISODIUM (90MG/10ML) | INJECTION | False | AP | 2002-05-17 | PAMIDRONATE DISODIUM |
| 14 | ANDA077433_001 | RX | PAMIDRONATE DISODIUM (30MG/VIAL) | INJECTION | False | AP | 2008-11-26 | PAMIDRONATE DISODIUM |
| 15 | ANDA077433_002 | RX | PAMIDRONATE DISODIUM (60MG/VIAL) | INJECTION | False | AP | 2008-11-26 | PAMIDRONATE DISODIUM |
| 16 | ANDA077433_003 | RX | PAMIDRONATE DISODIUM (90MG/VIAL) | INJECTION | False | AP | 2008-11-26 | PAMIDRONATE DISODIUM |
| 17 | ANDA077703_001 | RX | PAMIDRONATE DISODIUM (30MG/VIAL) | INJECTION | False | AP | 2008-12-24 | PAMIDRONATE DISODIUM |
| 18 | ANDA077703_002 | RX | PAMIDRONATE DISODIUM (90MG/VIAL) | INJECTION | False | AP | 2008-12-24 | PAMIDRONATE DISODIUM |
| 19 | ANDA078156_001 | RX | PAMIDRONATE DISODIUM (30MG/10ML) | INJECTION | False | AP | 2008-08-19 | PAMIDRONATE DISODIUM |
| 20 | ANDA078156_002 | RX | PAMIDRONATE DISODIUM (60MG/10ML) | INJECTION | False | AP | 2008-08-19 | PAMIDRONATE DISODIUM |
| 21 | ANDA078156_003 | RX | PAMIDRONATE DISODIUM (90MG/10ML) | INJECTION | False | AP | 2008-08-19 | PAMIDRONATE DISODIUM |
| 22 | ANDA078300_001 | discontinued | PAMIDRONATE DISODIUM (30MG/VIAL) | INJECTION | False | 2009-03-10 | PAMIDRONATE DISODIUM | |
| 23 | ANDA078300_002 | discontinued | PAMIDRONATE DISODIUM (90MG/VIAL) | INJECTION | False | 2009-03-10 | PAMIDRONATE DISODIUM | |
| 24 | ANDA078373_001 | RX | PAMIDRONATE DISODIUM (30MG/10ML) | INJECTION | False | AP | 2008-12-23 | PAMIDRONATE DISODIUM |
| 25 | ANDA078373_002 | RX | PAMIDRONATE DISODIUM (90MG/10ML) | INJECTION | False | AP | 2008-12-23 | PAMIDRONATE DISODIUM |
| 26 | ANDA078520_001 | RX | PAMIDRONATE DISODIUM (30MG/10ML) | INJECTION | False | AP | 2008-10-31 | PAMIDRONATE DISODIUM |
| 27 | ANDA078520_002 | RX | PAMIDRONATE DISODIUM (90MG/10ML) | INJECTION | False | AP | 2008-10-31 | PAMIDRONATE DISODIUM |
| 28 | ANDA078942_001 | RX | PAMIDRONATE DISODIUM (30MG/10ML) | INJECTION | False | AP | 2008-07-25 | PAMIDRONATE DISODIUM |
| 29 | ANDA078942_002 | RX | PAMIDRONATE DISODIUM (90MG/10ML) | INJECTION | False | AP | 2008-07-25 | PAMIDRONATE DISODIUM |
| 30 | NDA020036_001 | discontinued | PAMIDRONATE DISODIUM (30MG/VIAL) | INJECTION | False | 1991-10-31 | AREDIA | |
| 31 | NDA020036_003 | discontinued | PAMIDRONATE DISODIUM (60MG/VIAL) | INJECTION | False | 1993-05-06 | AREDIA | |
| 32 | NDA020036_004 | discontinued | PAMIDRONATE DISODIUM (90MG/VIAL) | INJECTION | False | 1993-05-06 | AREDIA | |
| 33 | NDA021113_001 | RX | PAMIDRONATE DISODIUM (30MG/10ML) | INJECTION | True | AP | 2002-03-04 | PAMIDRONATE DISODIUM |
| 34 | NDA021113_002 | RX | PAMIDRONATE DISODIUM (90MG/10ML) | INJECTION | True | AP | 2002-03-04 | PAMIDRONATE DISODIUM |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 246ad093-0419-48a2-8d11-f2c5806156c1 (view SPL) | PAMIDRONATE DISODIUM INJECTION | prescription | Human Prescription | Sagent Pharmaceuticals | MANUFACTURE | 2009-11-03 | 2 | 250210802, 250210803 |
| 2 | 5db8c103-2bfd-a235-d50d-4c1a356d44d2 (view SPL) | Pamidronate Disodium for Injection USP For Intravenous Infusion Rx only | prescription | Human Prescription | Areva Pharmaceuticals,Inc. | MANUFACTURE | 2012-09-06 | 2 | 599230601, 599230602, 599230603 |
| 3 | 82e8deb5-2368-4267-8286-b7782acca952 (view SPL) | Pamidronate Disodium Injection | prescription | Human Prescription | Mylan Institutional Llc | Analysis, Label, Manufacture, Pack, Sterilize | 2014-10-17 | 1 | 674570610 |
| 4 | 9337c108-2d51-4322-be3c-f3e879069f86 (view SPL) | PAMIDRONATE DISODIUM INJECTION | prescription | Human Prescription | American Regent, Inc. | ANALYSIS, MANUFACTURE | 2015-03-09 | 4 | 005170745, 005170746 |
| 5 | 9b6a9a3b-71c9-4dcb-b857-5d1de25c3a23 (view SPL) | Pamidronate Disodium Injection | prescription | Human Prescription | Hospira Worldwide, Inc. | 2014-07-22 | 13 | 617030324, 617030325, 617030326 | |
| 6 | a8ba3ed0-7047-400e-8037-ebc058024637 (view SPL) | pamidronate disodium injection | prescription | Human Prescription | Pfizer Labs | ANALYSIS, API MANUFACTURE, MANUFACTURE | 2011-02-25 | 2 | 000690107, 000690109 |
| 7 | ad1b83f9-ddf7-44b7-9234-77d6872e4825 (view SPL) | Pamidronate Disodium Injection | prescription | Human Prescription | App Pharmaceuticals, Llc | MANUFACTURE | 2011-08-08 | 1 | 633230734, 633230735 |
| 8 | c2ca033e-fa5f-4141-b702-11f8b4303da1 (view SPL) | Pamidronate Disodium Injection | prescription | Human Prescription | Mylan Institutional Llc | Analysis, Label, Manufacture, Pack, Sterilize | 2014-01-03 | 1 | 674570430 |
| 9 | d3f15563-21af-4e0d-a9f1-1ebc596c848f (view SPL) | These highlights do not include all the information needed to use pamidronate disodium injection safely and effectively. See full prescribing information for pamidronate disodium injection. PAMIDRONATE DISODIUM injection, for intravenous use Initial U.S. Approval: 1991 | prescription | Human Prescription | Teva Parenteral Medicines, Inc | 2015-02-05 | 9 | 007034075, 007034085 | |
| 10 | ebd26191-b497-4904-b158-ca3b0bcd178b (view SPL) | Pamidronate Disodium Injection | prescription | Human Prescription | Pfizer Labs | API MANUFACTURE, MANUFACTURE | 2013-11-21 | 2 | 000690186 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII