Home Applications 087953 Application 087953
Type ANDA
Sponsor WOCKHARDT BIO AG Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PROMETHAZINE PLAIN PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 6.25MG/5ML No Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A087953-001 PROMETHAZINE PLAIN PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A087953-001 AA
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RS 1982-11-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RS 1982-11-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RS 1982-11-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RS 1982-11-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RS 1982-11-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RS 1982-11-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RS 1982-11-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RS 1982-11-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 17856-0608 Promethazine Hydrochloride Promethazine Hydrochloride Atlantic Biologicals Corps ANDA Current 17856-0608 Promethazine Hydrochloride Promethazine Hydrochloride ATLANTIC BIOLOGICALS CORP. ANDA Current 21695-703 Promethazine Hydrochloride Promethazine Hydrochloride Rebel Distributors Corp ANDA Current 50090-4124 PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride A-S Medication Solutions ANDA Current 50090-4124 PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride A-S Medication Solutions ANDA Current 60432-608 PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride Morton Grove Pharmaceuticals, Inc. ANDA Current 60432-608 PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride Morton Grove Pharmaceuticals, Inc. ANDA Current 63187-338 Promethazine Hydrochloride Promethazine Hydrochloride Proficient Rx LP ANDA Current