Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080873
Company: DR REDDYS
Company: DR REDDYS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | 50MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE | DIPHENHYDRAMINE HYDROCHLORIDE | 50MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 01/29/1974 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/22/1999 | SUPPL-218 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/19/1999 | SUPPL-216 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 02/02/1999 | SUPPL-215 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 01/15/1997 | SUPPL-214 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/16/1996 | SUPPL-213 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 02/11/1989 | SUPPL-212 | Bioequivalence |
Label is not available on this site. |
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| 11/04/1993 | SUPPL-211 | Labeling |
Label is not available on this site. |
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| 12/23/1988 | SUPPL-210 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/12/1989 | SUPPL-206 | Labeling |
Label is not available on this site. |
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| 01/12/1988 | SUPPL-204 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/12/1988 | SUPPL-203 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/02/1986 | SUPPL-202 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/01/1985 | SUPPL-201 | Manufacturing (CMC) |
Label is not available on this site. |