Application 208620
- Type
- ANDA
- Sponsor
- DR REDDYS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TESTOSTERONE | TESTOSTERONE | GEL, METERED;TRANSDERMAL | 1.62% (20.25MG/1.25GM ACTUATION) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A208620-001 | TESTOSTERONE | TESTOSTERONE | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED / TRANSDERMAL | AB | 2019-04-10 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A208620-001 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A208620-001 | TESTOSTERONE | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED / TRANSDERMAL | AB | 2019-04-10 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A208620-001 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| TESTOSTERONE | TESTOSTERONE | Encube Ethicals, Inc. | 44a04f66-fd2a-45c7-934e-8f14c023ce14 | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | 208620 ANDA208620 |
| Testosterone | TESTOSTERONE | Dr. Reddy's Laboratories, Inc. | ccadef00-3d5f-f926-e0fb-8dabe859f271 | 2019-05-21 | Boxed warning, Warnings, Adverse reactions | 208620 ANDA208620 43598-304 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 43598-304 | Testosterone | Testosterone | Dr. Reddy's Laboratories, Inc. | ANDA | Current |
| 43598-304 | Testosterone | Testosterone | Dr. Reddy's Laboratories, Inc. | ANDA | Current |
| 43598-304 | Testosterone | Testosterone | Dr. Reddy's Laboratories, Inc. | ANDA | Current |