Acyclovir Oral Suspension
- Brand(s)
- Zovirax
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Renaissance Pharma, Inc. (2014-09-04)
- Oldest Current Product
- 2002-09-03
- License(s)
- NDA, NDA AUTHORIZED GENERIC, ANDA
- RxNORM
- ORAL SUSPENSION\ACYCLOVIR
- FDAOB
- ORAL\SUSPENSION\ACYCLOVIR
- SPL Active
- ORAL\SUSPENSION\ACYCLOVIR
- SPL Moiety
- ORAL\SUSPENSION\ACYCLOVIR
product(s) by strength(s)
acyclovir 40 mg/ml oral suspension
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 400760953 | Zovirax | NDA | Prestium Pharma, Inc. | 2014-02-07 | ACYCLOVIR | ORAL | SUSPENSION | NDA019909 | 6fe0ab86-9d81-461e-9c84-6ba724a91318 |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 004720082 | ANDA | Actavis Pharma, Inc. | 2002-09-03 | ACYCLOVIR | ORAL | SUSPENSION | ANDA074738 | a4c1305c-f18c-4fb0-83d8-2822341f2dfa |
| 2 | 400850842 | NDA AUTHORIZED GENERIC | Renaissance Pharma, Inc. | 2014-09-03 | ACYCLOVIR | ORAL | SUSPENSION | NDA019909 | c99d1396-4d4d-4890-aa09-5dfcdc3e7ece |
| 3 | 503830810 | ANDA | Hi-Tech Pharmacal Co., Inc. | 2005-06-07 | ACYCLOVIR | ORAL | SUSPENSION | ANDA077026 | 62bdcf22-51f3-4c81-9bd4-a2dc48bec580 |
relabeler product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 178560082 | ANDA | Atlantic Biologicals Corps | 2005-06-07 | ACYCLOVIR | ORAL | SUSPENSION | 503830810 | ANDA077026 | 300bb5fb-557c-4045-993f-fcc895b4bd3f |
| 2 | 548685687 | ANDA | Physicians Total Care, Inc. | 2006-10-03 | ACYCLOVIR | ORAL | SUSPENSION | 50383081016 | ANDA077026 | dcc29902-1fe6-4713-947e-335503959464 |
| 3 | 687880715 | ANDA | Preferred Pharmaceuticals, Inc. | 2011-03-18 | ACYCLOVIR | ORAL | SUSPENSION | 503830810 | ANDA077026 | 0a1eb087-50a2-441a-a3fe-3d93e31fe39f |
| 4 | 687889783 | ANDA | Preferred Pharmaceuticals, Inc. | 2012-07-27 | ACYCLOVIR | ORAL | SUSPENSION | 004720082 | ANDA074738 | bdee576a-24bf-41a0-b948-e4c8a33cc8d0 |
application(s)
| # | id | title | applicant | approved | approved drug |
|---|---|---|---|---|---|
| 1 | ANDA074738 | ACYCLOVIR | ACTAVIS MID ATLANTIC LLC | 1997-04-28 | ANDA074738_001 |
| 2 | ANDA077026 | ACYCLOVIR | HI TECH PHARMACAL CO INC | 2005-06-07 | ANDA077026_001 |
| 3 | NDA019909 | ZOVIRAX | DELCOR ASSET CORP | 1989-12-22 | NDA019909_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|---|
| 1 | ANDA074738_001 | RX | ACYCLOVIR (200MG/5ML) | ORAL | SUSPENSION | False | AB | 1997-04-28 | ACYCLOVIR |
| 2 | ANDA077026_001 | RX | ACYCLOVIR (200MG/5ML) | ORAL | SUSPENSION | False | AB | 2005-06-07 | ACYCLOVIR |
| 3 | NDA019909_001 | RX | ACYCLOVIR (200MG/5ML) | ORAL | SUSPENSION | True | AB | 1989-12-22 | ZOVIRAX |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) | in other drug docs |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 0a1eb087-50a2-441a-a3fe-3d93e31fe39f (view SPL) | Acyclovir Oral Suspension, USP | prescription | Human Prescription | Preferred Pharmaceuticals, Inc. | RELABEL | 2013-12-24 | 5 | 687880715 | |
| 2 | 300bb5fb-557c-4045-993f-fcc895b4bd3f (view SPL) | Acyclovir Oral Suspension, USP | prescription | Human Prescription | Atlantic Biologicals Corps | RELABEL, REPACK | 2010-06-16 | 3 | 178560082 | |
| 3 | 62bdcf22-51f3-4c81-9bd4-a2dc48bec580 (view SPL) | Acyclovir Oral Suspension, USP | prescription | Human Prescription | Hi-Tech Pharmacal Co., Inc. | 2010-06-16 | 2 | 503830810 | ||
| 4 | 6fe0ab86-9d81-461e-9c84-6ba724a91318 (view SPL) | ZOVIRAX (acyclovir) Capsules ZOVIRAX (acyclovir) Tablets ZOVIRAX (acyclovir) Suspension | prescription | Human Prescription | Prestium Pharma, Inc. | MANUFACTURE | 2014-02-10 | 1 | 400760953, 400760945, 400760949, 400760991 | Acyclovir Oral Tablet Acyclovir Oral Capsule |
| 5 | a4c1305c-f18c-4fb0-83d8-2822341f2dfa (view SPL) | ACYCLOVIR ORAL SUSPENSION USP | prescription | Human Prescription | Actavis Pharma, Inc. | 2010-05-12 | 2 | 004720082 | ||
| 6 | bdee576a-24bf-41a0-b948-e4c8a33cc8d0 (view SPL) | ACYCLOVIR ORAL SUSPENSION USP FORM NO. 0082 VC3361 Rev. 05/09 Rx Only | prescription | Human Prescription | Preferred Pharmaceuticals, Inc. | RELABEL | 2012-07-27 | 1 | 687889783 | |
| 7 | c99d1396-4d4d-4890-aa09-5dfcdc3e7ece (view SPL) | Acyclovir Suspension | prescription | Human Prescription | Renaissance Pharma, Inc. | MANUFACTURE | 2014-09-04 | 2 | 400850842 | |
| 8 | dcc29902-1fe6-4713-947e-335503959464 (view SPL) | prescription | Human Prescription | Physicians Total Care, Inc. | relabel | 2010-07-09 | 1 | 548685687 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII