Application 020238
- Type
- NDA
- Sponsor
- MEDTECH PRODUCTS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TAGAMET HB | CIMETIDINE | TABLET;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | TAGAMET HB | CIMETIDINE | TABLET;ORAL | 200MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020238-001 | TAGAMET HB | CIMETIDINE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-06-19 | |
| N020238-002 | TAGAMET HB | CIMETIDINE | 200MG | TABLET / ORAL | RLD, RS | 1996-08-21 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | N020238-001 | TAGAMET HB | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-06-19 | f41ea6bd6efb… | |
| 2022-10-28 04:53 UTC | 2022-10 | N020238-002 | TAGAMET HB | 200MG | TABLET / ORAL | RLD, RS | 1996-08-21 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N020238-001 | TAGAMET HB | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-06-19 | e64feba35796… | |
| 2022-09-29 23:25 UTC | 2022-09 | N020238-002 | TAGAMET HB | 200MG | TABLET / ORAL | RLD, RS | 1996-08-21 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N020238-001 | TAGAMET HB | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-06-19 | cb3db0bc1861… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N020238-002 | TAGAMET HB | 200MG | TABLET / ORAL | RLD, RS | 1996-08-21 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N020238-001 | TAGAMET HB | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-06-19 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N020238-002 | TAGAMET HB | 200MG | TABLET / ORAL | RLD, RS | 1996-08-21 | a50c72e98297… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Tagamet | CIMETIDINE | Medtech Products Inc. | e6401e0a-8612-42e8-bf89-2d67243f28dc | 2024-06-10 | Warnings | 020238 NDA020238 63029-222 |
| TAGAMET | CIMETIDINE | Prestige Brands Holdings, Inc. | c8ba8815-9d99-439f-b397-3869f729d9f4 | 2023-01-20 | Warnings | 020238 NDA020238 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 63029-222 | Tagamet | Cimetidine | Medtech Products Inc. | NDA | Current |
| 63029-222 | Tagamet | Cimetidine | Medtech Products Inc. | NDA | Current |
| 63029-222 | Tagamet | Cimetidine | Medtech Products Inc. | NDA | Current |
| 63029-222 | Tagamet | Cimetidine | Medtech Products Inc. | NDA | Current |
| 63029-222 | Tagamet | Cimetidine | Medtech Products Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 71187 | SUPPL | 2022-06-01 |
| 71147 | SUPPL | 2022-05-25 |
| 67993 | SUPPL | 2021-06-30 |
| 67914 | SUPPL | 2021-06-28 |
| 62562 | SUPPL | 2020-04-14 |
| 62561 | SUPPL | 2020-04-14 |
| 58096 | SUPPL | 2019-03-27 |
| 58093 | SUPPL | 2019-03-27 |
| 20548 | SUPPL | 2008-07-30 |
| 2225 | SUPPL | 2008-02-13 |
| 24633 | SUPPL | 2006-10-05 |
| 12352 | SUPPL | 2005-05-17 |
| 2224 | SUPPL | 2005-05-17 |