Gentamicin Sulfate (USP) Ophthalmic Solution
- Brand(s)
- Garamycin
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Bausch & Lomb Incorporated (2013-06-20)
- Oldest Current Product
- 1984-10-10
- License(s)
- ANDA
- RxNORM
- OPHTHALMIC SOLUTION\GENTAMICIN SULFATE (USP)
- FDAOB
- OPHTHALMIC\SOLUTION_DROPS\GENTAMICIN SULFATE
- SPL Active
- OPHTHALMIC\SOLUTION/DROPS\GENTAMICIN SULFATE
OPHTHALMIC\SOLUTION\GENTAMICIN SULFATE - SPL Moiety
- OPHTHALMIC\SOLUTION/DROPS\GENTAMICIN
OPHTHALMIC\SOLUTION\GENTAMICIN
product(s) by strength(s)
gentamicin sulfate (usp) 3 mg/ml ophthalmic solution
generic product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 005744072 | Garamycin | ANDA | Paddock Laboratories, Llc | 2014-06-05 | GENTAMICIN SULFATE | OPHTHALMIC | SOLUTION | ANDA065121 | c4dafa35-2e51-4c24-9516-f5c8b716e091 |
| 2 | 174780283 | ANDA | Akorn | 2006-12-13 | GENTAMICIN SULFATE | OPHTHALMIC | SOLUTION/DROPS | ANDA064163 | 877ab1fd-6c0e-42f6-9522-f5efaa96018d | |
| 3 | 174780826 | ANDA | Akorn | 2013-03-11 | GENTAMICIN SULFATE | OPHTHALMIC | SOLUTION/DROPS | ANDA064163 | 32d5af97-70bd-4ee4-81d4-67578dc677a0 | |
| 4 | 242080580 | ANDA | Bausch & Lomb Incorporated | 1994-05-11 | GENTAMICIN SULFATE | OPHTHALMIC | SOLUTION/DROPS | ANDA064048 | 41d01350-5c4b-42fc-be5f-986ceec02bd3 | |
| 5 | 481020022 | Garamycin | ANDA | Fera Pharmaceuticals | 2011-05-15 | GENTAMICIN SULFATE | OPHTHALMIC | SOLUTION/DROPS | ANDA065121 | aa2b006d-f67c-4c71-abce-55d55295b5bb |
| 6 | 607580188 | ANDA | Pacific Pharma, Inc. | 1998-01-05 | GENTAMICIN SULFATE | OPHTHALMIC | SOLUTION/DROPS | ANDA062452 | 0bc9fa00-1755-4989-a222-a038e970371f | |
| 7 | 613140633 | ANDA | Sandoz Inc | 1996-04-05 | GENTAMICIN SULFATE | OPHTHALMIC | SOLUTION | ANDA062196 | a213fb9c-08ea-4f30-a6c9-93c7a9ba5280 |
relabeler product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 216950187 | ANDA | Rebel Distributors Corp | 1984-10-10 | GENTAMICIN SULFATE | OPHTHALMIC | SOLUTION | 607580188 | ANDA062452 | d7a27e38-0553-4d4b-8438-fed235e9b989 |
| 2 | 332610604 | ANDA | Aidarex Pharmaceuticals Llc | 1998-01-05 | GENTAMICIN SULFATE | OPHTHALMIC | SOLUTION/DROPS | 607580188 | ANDA062452 | 2e647e36-15d9-49e9-b81b-35465441e37a |
| 3 | 353560707 | ANDA | Lake Erie Medical Dba Quality Care Products Llc | 1998-01-05 | GENTAMICIN SULFATE | OPHTHALMIC | SOLUTION/DROPS | 607580188 | ANDA062452 | c868d3fb-0a00-445b-a40d-bd0627293815 |
| 4 | 458650672 | ANDA | Medsource Pharmaceuticals | 1994-05-11 | GENTAMICIN SULFATE | OPHTHALMIC | SOLUTION/DROPS | 242080580 | ANDA064048 | 1f908b73-d829-4c6f-e054-00144ff8d46c |
| 5 | 499990138 | ANDA | Lake Erie Medical Dba Quality Care Products Llc | 2012-03-12 | GENTAMICIN SULFATE | OPHTHALMIC | SOLUTION/DROPS | 242080580 | ANDA064048 | 5106f179-0413-41c7-b93f-786b0d515129 |
| 6 | 504366752 | ANDA | Unit Dose Services | 1994-05-11 | GENTAMICIN SULFATE | OPHTHALMIC | SOLUTION/DROPS | 242080580 | ANDA064048 | c3a08907-778d-4229-9f72-20cc4f57b10c |
| 7 | 521250461 | ANDA | Remedyrepack Inc. | 2013-07-05, 2013-12-05 | GENTAMICIN SULFATE | OPHTHALMIC | SOLUTION/DROPS | 607580188 | ANDA062452 | 4687a0ea-4dd3-4e7b-9124-b65c3aef3485, 9245b639-cd83-4868-b96a-d343b48496bd |
| 8 | 545691218 | ANDA | A-S Medication Solutions Llc | 1994-05-11 | GENTAMICIN SULFATE | OPHTHALMIC | SOLUTION/DROPS | 242080580 | ANDA064048 | b0a2b7af-85f1-4e49-a270-ca69e9fd539c |
| 9 | 548686745 | ANDA | Physicians Total Care, Inc. | 1993-09-17 | GENTAMICIN SULFATE | OPHTHALMIC | SOLUTION/DROPS | 242080580 | ANDA064048 | fcb5baef-4760-4bb3-88dd-e3c3e3bb1a5d |
| 10 | 581189893 | ANDA | Clinical Solutions Wholesale | 1994-05-11 | GENTAMICIN SULFATE | OPHTHALMIC | SOLUTION/DROPS | 242080580 | ANDA064048 | e1256852-fbe7-441e-8d39-1c78c9805ddb |
| 11 | 619190106 | ANDA | Direct Rx | 2014-01-01 | GENTAMICIN SULFATE | OPHTHALMIC | SOLUTION/DROPS | 607580188 | ANDA062452 | 51a411a0-2671-4c1c-bf25-e29b32efed0c |
| 12 | 631870163 | ANDA | Proficient Rx Lp | 1998-01-05 | GENTAMICIN SULFATE | OPHTHALMIC | SOLUTION/DROPS | 607580188 | ANDA062452 | 3ab508ed-4b12-4dd7-a13e-1a071f560286 |
| 13 | 631870560 | ANDA | Proficient Rx Lp | 1994-05-11 | GENTAMICIN SULFATE | OPHTHALMIC | SOLUTION/DROPS | 242080580 | ANDA064048 | 3a6677a6-def5-443e-82bc-c185d41f03b7 |
| 14 | 687880633 | ANDA | Preferred Pharmaceuticals, Inc. | 2013-03-14 | GENTAMICIN SULFATE | OPHTHALMIC | SOLUTION/DROPS | 242080580 | ANDA064048 | c5fac820-18a1-452f-bc2c-58ed73babb0c |
| 15 | 687889921 | ANDA | Preferred Pharmaceuticals, Inc. | 2014-03-25 | GENTAMICIN SULFATE | OPHTHALMIC | SOLUTION/DROPS | 607580188 | ANDA062452 | 6a8e95ad-0a33-4d97-b44c-57555ccdf83a |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug | in other drug docs |
|---|---|---|---|---|---|---|---|
| 1 | ANDA062196 | GENTAMICIN SULFATE | ALCON RESEARCH LTD | ANDA062196_001 | Gentamicin Sulfate (USP) Ophthalmic Ointment | ||
| 2 | ANDA062440 | GENTAFAIR | True | PHARMAFAIR INC | 1983-05-03 | ANDA062440_001 | Gentamicin Sulfate (USP) Ophthalmic Ointment |
| 3 | ANDA062452 | GENOPTIC | ALLERGAN | 1984-10-10 | ANDA062452_001 | Gentamicin Sulfate (USP) Ophthalmic Ointment | |
| 4 | ANDA062480 | GENTACIDIN | True | NOVARTIS PHARMACEUTICALS CORP | 1984-03-30 | ANDA062480_001 | Gentamicin Sulfate (USP) Ophthalmic Ointment |
| 5 | ANDA062523 | GENTAMICIN SULFATE | True | ALCON PHARMACEUTICALS LTD | 1985-11-25 | ANDA062523_001 | Gentamicin Sulfate (USP) Ophthalmic Ointment |
| 6 | ANDA062635 | GENTAMICIN SULFATE | AKORN INC | 1987-01-08 | ANDA062635_001 | Gentamicin Sulfate (USP) Ophthalmic Ointment | |
| 7 | ANDA062932 | GENTAMICIN SULFATE | True | PACO RESEARCH CORP | 1988-11-07 | ANDA062932_001 | Gentamicin Sulfate (USP) Ophthalmic Ointment |
| 8 | ANDA064048 | GENTAMICIN SULFATE | BAUSCH AND LOMB PHARMACEUTICALS INC | 1994-05-11 | ANDA064048_001 | Gentamicin Sulfate (USP) Ophthalmic Ointment | |
| 9 | ANDA064163 | GENTAK | AKORN INC | 2001-10-12 | ANDA064163_001 | Gentamicin Sulfate (USP) Ophthalmic Ointment | |
| 10 | ANDA065121 | GENTAMICIN SULFATE | PERRIGO CO TENNESSEE INC | 2004-01-30 | ANDA065121_001 | Gentamicin Sulfate (USP) Ophthalmic Ointment | |
| 11 | NDA050039 | GARAMYCIN | True | SCHERING CORP SUB SCHERING PLOUGH CORP | NDA050039_002 | Gentamicin Sulfate (USP) Ophthalmic Ointment |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|---|
| 1 | ANDA062196_001 | RX | GENTAMICIN SULFATE (EQ 0.3% BASE) | OPHTHALMIC | SOLUTION/DROPS | False | AT | GENTAMICIN SULFATE | |
| 2 | ANDA062440_001 | discontinued | GENTAMICIN SULFATE (EQ 0.3% BASE) | OPHTHALMIC | SOLUTION/DROPS | False | 1983-05-03 | GENTAFAIR | |
| 3 | ANDA062452_001 | RX | GENTAMICIN SULFATE (EQ 0.3% BASE) | OPHTHALMIC | SOLUTION/DROPS | False | AT | 1984-10-10 | GENOPTIC |
| 4 | ANDA062480_001 | discontinued | GENTAMICIN SULFATE (EQ 0.3% BASE) | OPHTHALMIC | SOLUTION/DROPS | False | 1984-03-30 | GENTACIDIN | |
| 5 | ANDA062523_001 | discontinued | GENTAMICIN SULFATE (EQ 0.3% BASE) | OPHTHALMIC | SOLUTION/DROPS | False | 1985-11-25 | GENTAMICIN SULFATE | |
| 6 | ANDA062635_001 | RX | GENTAMICIN SULFATE (EQ 0.3% BASE) | OPHTHALMIC | SOLUTION/DROPS | False | AT | 1987-01-08 | GENTAMICIN SULFATE |
| 7 | ANDA062932_001 | discontinued | GENTAMICIN SULFATE (EQ 3MG BASE/ML) | OPHTHALMIC | SOLUTION/DROPS | False | 1988-11-07 | GENTAMICIN SULFATE | |
| 8 | ANDA064048_001 | RX | GENTAMICIN SULFATE (EQ 0.3% BASE) | OPHTHALMIC | SOLUTION/DROPS | True | AT | 1994-05-11 | GENTAMICIN SULFATE |
| 9 | ANDA064163_001 | RX | GENTAMICIN SULFATE (EQ 0.3% BASE) | OPHTHALMIC | SOLUTION/DROPS | False | AT | 2001-10-12 | GENTAK |
| 10 | ANDA065121_001 | RX | GENTAMICIN SULFATE (EQ 0.3% BASE) | OPHTHALMIC | SOLUTION/DROPS | False | AT | 2004-01-30 | GENTAMICIN SULFATE |
| 11 | NDA050039_002 | discontinued | GENTAMICIN SULFATE (EQ 0.3% BASE) | OPHTHALMIC | SOLUTION/DROPS | False | GARAMYCIN |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 0bc9fa00-1755-4989-a222-a038e970371f (view SPL) | GENTAMICIN SULFATEophthalmic solution, USP 0.3%sterile | prescription | Human Prescription | Pacific Pharma, Inc. | MANUFACTURE | 2013-08-31 | 4 | 607580188 |
| 2 | 1f908b73-d829-4c6f-e054-00144ff8d46c (view SPL) | Gentamicin Sulfate Ophthalmic Solution USP, 0.3% (Sterile) | prescription | Human Prescription | Medsource Pharmaceuticals | relabel | 2015-09-12 | 1 | 458650672 |
| 3 | 2e647e36-15d9-49e9-b81b-35465441e37a (view SPL) | GENTAMICIN SULFATEophthalmic solution, USP 0.3%sterile | prescription | Human Prescription | Aidarex Pharmaceuticals Llc | 2014-01-03 | 1 | 332610604 | |
| 4 | 32d5af97-70bd-4ee4-81d4-67578dc677a0 (view SPL) | Gentamicin Sulfate Ophthalmic SolutionUSP,0.3%Sterile | prescription | Human Prescription | Akorn | ANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE | 2013-03-08 | 1 | 174780826 |
| 5 | 3a6677a6-def5-443e-82bc-c185d41f03b7 (view SPL) | Gentamicin Sulfate Ophthalmic Solution USP, 0.3% (Sterile) | prescription | Human Prescription | Proficient Rx Lp | RELABEL, REPACK | 2015-02-01 | 1 | 631870560 |
| 6 | 3ab508ed-4b12-4dd7-a13e-1a071f560286 (view SPL) | GENTAMICIN SULFATE ophthalmic solution, USP 0.3% sterile | prescription | Human Prescription | Proficient Rx Lp | RELABEL, REPACK | 2014-09-01 | 1 | 631870163 |
| 7 | 41d01350-5c4b-42fc-be5f-986ceec02bd3 (view SPL) | Gentamicin Sulfate Ophthalmic Solution USP, 0.3% (Sterile) | prescription | Human Prescription | Bausch & Lomb Incorporated | MANUFACTURE | 2013-06-20 | 5 | 242080580 |
| 8 | 4687a0ea-4dd3-4e7b-9124-b65c3aef3485 (view SPL) | GENTAMICIN SULFATEOphthalmic Solution, USP 0.3% | prescription | Human Prescription | Remedyrepack Inc. | 2013-12-05 | 1 | 521250461 | |
| 9 | 5106f179-0413-41c7-b93f-786b0d515129 (view SPL) | Gentamicin SulfateOphthalmic Solution USP, 0.3% (Sterile) | prescription | Human Prescription | Lake Erie Medical Dba Quality Care Products Llc | MANUFACTURE, relabel | 2012-03-13 | 3642 | 499990138 |
| 10 | 51a411a0-2671-4c1c-bf25-e29b32efed0c (view SPL) | gentamicin sulfate | prescription | Human Prescription | Direct Rx | relabel | 2015-01-02 | 1 | 619190106 |
| 11 | 6a8e95ad-0a33-4d97-b44c-57555ccdf83a (view SPL) | GENTAMICIN SULFATE ophthalmic solution, USP 0.3% sterile | prescription | Human Prescription | Preferred Pharmaceuticals, Inc. | RELABEL | 2014-03-25 | 2 | 687889921 |
| 12 | 877ab1fd-6c0e-42f6-9522-f5efaa96018d (view SPL) | Gentamicin Sulfate Ophthalmic Solution USP, 0.3% | prescription | Human Prescription | Akorn | ANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE | 2012-08-10 | 2 | 174780283 |
| 13 | 9245b639-cd83-4868-b96a-d343b48496bd (view SPL) | GENTAMICIN SULFATEOphthalmic Solution, USP 0.3% | prescription | Human Prescription | Remedyrepack Inc. | 2013-07-05 | 1 | 521250461 | |
| 14 | a213fb9c-08ea-4f30-a6c9-93c7a9ba5280 (view SPL) | Gentamicin Sulfate Ophthalmic Solution USP | prescription | Human Prescription | Sandoz Inc | 2014-08-27 | 4 | 613140633 | |
| 15 | aa2b006d-f67c-4c71-abce-55d55295b5bb (view SPL) | prescription | Human Prescription | Fera Pharmaceuticals | 2011-04-26 | 1 | 481020022 | ||
| 16 | b0a2b7af-85f1-4e49-a270-ca69e9fd539c (view SPL) | Gentamicin SulfateOphthalmic Solution USP, 0.3% (Sterile) | prescription | Human Prescription | A-S Medication Solutions Llc | relabel | 2013-06-29 | 1 | 545691218 |
| 17 | c3a08907-778d-4229-9f72-20cc4f57b10c (view SPL) | Gentamicin Sulfate Ophthalmic Solution USP, 0.3% (Sterile) | prescription | Human Prescription | Unit Dose Services | REPACK | 2013-06-20 | 2 | 504366752 |
| 18 | c4dafa35-2e51-4c24-9516-f5c8b716e091 (view SPL) | Garamycin gentamicin sulfate ophthalmic solution USP, 0.3% | prescription | Human Prescription | Paddock Laboratories, Llc | 2014-07-21 | 2 | 005744072 | |
| 19 | c5fac820-18a1-452f-bc2c-58ed73babb0c (view SPL) | Gentamicin Sulfate Ophthalmic Solution USP, 0.3% (Sterile) | prescription | Human Prescription | Preferred Pharmaceuticals, Inc. | RELABEL | 2014-03-25 | 2 | 687880633 |
| 20 | c868d3fb-0a00-445b-a40d-bd0627293815 (view SPL) | GENTAMICIN SULFATEOphthalmic Solution, USP 0.3% | prescription | Human Prescription | Lake Erie Medical Dba Quality Care Products Llc | relabel | 2012-06-28 | 3884 | 353560707 |
| 21 | d7a27e38-0553-4d4b-8438-fed235e9b989 (view SPL) | GENTAMICIN SULFATEOphthalmic Solution, USP 0.3% | prescription | Human Prescription | Rebel Distributors Corp | RELABEL, REPACK | 2010-09-27 | 1 | 216950187 |
| 22 | e1256852-fbe7-441e-8d39-1c78c9805ddb (view SPL) | Gentamicin Sulfate Ophthalmic Solution USP, 0.3% (Sterile) | prescription | Human Prescription | Clinical Solutions Wholesale | RELABEL | 2013-12-16 | 1 | 581189893 |
| 23 | fcb5baef-4760-4bb3-88dd-e3c3e3bb1a5d (view SPL) | Gentamicin SulfateOphthalmic Solution USP, 0.3% (Sterile) | prescription | Human Prescription | Physicians Total Care, Inc. | relabel | 2012-02-27 | 3 | 548686745 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII